Guidance

EU rules on the use of chemicals

Guidance on implementing REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) in businesses.

Overview

REACH entered into force on 1 June 2007 and is being implemented in stages to be completed by 1 June 2018. With over 30,000 substances on the EU market above 1 tonne per year, REACH was needed to address the issues including:

  • delays in assessing substances in previous regulations
  • increasing public concern and
  • very limited information available on hazards and risks to human health and the environment

The main objective of REACH is a high level of protection of human health and the environment, while maintaining the competitiveness and innovation of the EU chemicals industry. REACH provides a single regulatory framework for the control of chemicals, replacing the previous patchwork of controls, and ensures information on the properties of chemicals is transmitted down the supply chain, and enabling them to be safely handled.

Next steps for businesses

Now that the first phase-in registration deadline of 30 November 2010 has passed, businesses need to be careful not to relax too much, as there remains a lot to do regarding ongoing REACH implementation. 

Top of that list is the need to ensure that if you have been notified by the European Chemicals Agency (ECHA) that more information is needed for your registration, you must provide that by the deadline ECHA gives you for that, otherwise you may have to stop manufacturing or importing until you have submitted a successful registration.

For business that have successfully registered, the focus now needs to be on communicating updates to the Safety Data Sheets (SDSs) in your supply chains, particularly including the new extended SDS with exposure scenarios.

For businesses that have to register by 1 June 2013, don’t be fooled into thinking that you have plenty of time. 

Experience the first time around shows that preparations take much more time than initially thought, and the main thing to be concentrating on now is developing good supply chain communications between suppliers and downstream users to ensure all relevant information for registration is gathered.

Make sure that your Substance Information Exchange Forum (SIEF) is working, and there is a Lead Registrant in charge - if there isn’t consider doing that role yourself in order to get things moving quickly; it may cost you a bit more, but you certainly cannot afford to do nothing.  Your costs will pay back over the next couple of years.

To find out more about REACH and the UK Enforcement Regime for REACH including frequently asked questions, visit the UK REACH Competent Authority’s website.

You can also contact the Defra REACH team by email at reachteam@defra.gsi.gov.uk

The REACH Enforcement Regulations 2008 (SI 2008 No.2852) provide for the enforcement of REACH by

  • allocating responsibility for REACH to a number of enforcing authorities
  • providing these enforcing authorities with the powers they need; requiring enforcing authorities to cooperate and share information with other bodies connected to REACH enforcement and
  • setting the offences and penalties for contraventions of REACH requirements.

Animal testing

REACH makes it mandatory to share all existing animal test data within SIEFs, to avoid the need for duplicate tests. REACH has strong provisions to minimise the use of animal testing and the numbers of animals used in tests. The UK played a leading role in getting these provisions into the REACH legal text.

When putting together proposals for additional testing of substances to gather missing information for substance registrations, businesses must comply with the REACH requirements on the use of animal testing.

You can find more information on these requirements on the UK REACH Competent Authority’s website.

Authorisation

The first set of six substances of very high concern (SVHC) have now been placed on REACH Annex XIV, which means that in three to four years’ time they will be banned unless authorisations to continue specific uses have been granted by the European Commission. To find out what these substances are, and more information on the REACH authorisation process, visit the UK REACH Competent Authority’s website.

Evaluation

Now that the first registration deadline has passed, the evaluation element of REACH starts to work. There are two parts to this - dossier evaluation, where testing proposals are assessed and registration dossiers are checked for compliance, and substance evaluation, where substances considered to be of concern may be further examined by Member State Competent Authorities.

Dossier evaluation is starting now, while substance evaluation will begin in earnest in 2012.

More information on evaluation is available from the ECHA website.

Restriction

Restriction is the alternative method in REACH of controlling hazardous substances that do not fully meet the criteria for authorisation. It imposes harmonised controls on the uses of such substances across the EU, up to and including a complete ban as appropriate. Current restrictions are listed in REACH Annex XVII.

The UK REACH Competent Authority Steering Committee

The Competent Authority is overseen by a Steering Committee which comprises representatives of the four responsible authorities for REACH in the UK (ie the Secretary of State for the Environment, Food, and Rural Affairs, Scottish government ministers, Welsh Assembly government ministers, and Northern Ireland ministers), and other government departments with a significant interest in the implementation of REACH.

The Committee agrees the policies that the UK representatives put forward at EU-level REACH meetings, and also advises, supports, and holds to account the UK REACH Competent Authority as it delivers its tasks. 

Read the Competent Authority Steering Committee's terms of reference (PDF, 79KB, 2 pages) and latest minutes - Competent Authority Steering Committee: minutes, 27 January 2011 (PDF, 170KB, 10 pages)

For earlier minutes, please contact the Defra REACH team by email at reachteam@defra.gsi.gov.uk.

Guidance on the Reach processes

Due to the complex nature of implementing REACH there are a series of guidance documents that are aimed to help all stakeholders with their preparation for fulfilling their obligations under the REACH Regulation. These documents cover detailed guidance for a range of essential REACH process as well as for some specific scientific and/or technical methods that industry or authorities need to make use of under REACH.

These documents have been developed with the participation of many stakeholders: Industry, Member States and NGOs. The objective of these documents is to facilitate the implementation of REACH by describing good practice on how to fulfil their obligations. Further information can be found at the ECHA website and at the UK REACH Competent Authority’s website.

Evaluation of the EU REACH regulation

REACH requires each EU Member State to report to the European Commission every five years, starting from 1 June 2010, on the operation of REACH in their respective territories. Within the UK, queries on REACH operation and impacts may also come from a number of sources, such as Parliament, governments, industry, and non-governmental stakeholders.

A study commissioned by Defra drew up a detailed list of possible indicators, likely costs, what the confounding factors may be in measuring them successfully, and thus their feasibility and suitability for reporting on REACH impacts.  Defra is now considering how best to use this information in developing a system for monitoring and evaluating the operation and impact of REACH in the UK.  A copy of the scoping study is available here.

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